Systems and methods for conductive gel deployment

ABSTRACT

A therapy electrode system comprises a garment configured to be worn about a torso of a patient, a therapy electrode disposed in the garment and configured to deliver one or more electrical shocks to a body of the patient, a replaceable gel cartridge disposed on the therapy electrode and configured to release a conductive gel onto the patient&#39;s skin at an interface between the therapy electrode and the patient&#39;s skin prior to the delivery of the one or more electrical shocks to the body of the patient at the interface between the therapy electrode and the patient&#39;s skin, and a fluid pump in fluid communication with the replaceable gel cartridge.

RELATED APPLICATIONS

The present application claims priority under 35 U.S.C. § 120 as acontinuation of U.S. patent application Ser. No. 16/382,656, filed Apr.12, 2019, titled “SYSTEMS AND METHODS FOR CONDUCTIVE GEL DEPLOYMENT,”which in turn claims priority under 35 U.S.C. § 120 as a continuation ofU.S. patent application Ser. No. 15/826,892, filed Nov. 30, 2017, titled“SYSTEMS AND METHODS FOR CONDUCTIVE GEL DEPLOYMENT,” now U.S. Pat. No.10,300,266, which in turn claims priority under 35 U.S.C. § 120 as acontinuation of U.S. patent application Ser. No. 15/072,590, filed Mar.17, 2016, titled “SYSTEMS AND METHODS FOR CONDUCTIVE GEL DEPLOYMENT,”now U.S. Pat. No. 9,861,806, which in turn claims priority under 35U.S.C. § 119(e) to U.S. Provisional Patent Application Ser. No.62/135,495, filed Mar. 19, 2015, titled SYSTEMS AND METHODS FORCONDUCTIVE GEL DEPLOYMENT. Each of these applications is herebyincorporated herein by reference in its entirety for all purposes.

FIELD

Aspects and embodiments disclosed herein relate generally to medicaldevices.

BACKGROUND

Cardiac arrest and other cardiac health ailments are a major cause ofdeath worldwide. Various resuscitation efforts aim to maintain thebody's circulatory and respiratory systems during cardiac arrest in anattempt to save the life of the victim. The sooner these resuscitationefforts begin, the better the victim's chances of survival. Theseefforts are expensive and have a limited success rate, and cardiacarrest, among other conditions, continues to claim the lives of victims.

SUMMARY

In accordance with an aspect disclosed herein there is provided anelectrode system. The electrode system comprises a gel deploymentreceptacle configured to release a conductive gel onto a body of asubject and a fluid pump in fluid communication with the gel deploymentreceptacle.

In some embodiments, the electrode system is capable of delivering adefibrillation current. The electrode system may be disposed within awearable defibrillator device. The conductive gel may be capable ofconducting a defibrillation current.

In some embodiments, the fluid pump receives a fluid at a first pressureand outputs the fluid at a second pressure higher than the firstpressure. The fluid pump may be an air pump. The second pressure may bebetween about 10 psig and about 20 psig.

In some embodiments, the gel deployment receptacle comprises a shelldefining a gel chamber housing a conductive gel, a fluid inlet in fluidcommunication with the gel chamber, and a plurality of apertures influid communication with the gel chamber.

In some embodiments, the gel chamber is defined on a first side of theshell. The plurality of apertures may include a plurality of shellapertures defined in a second side of the shell.

In some embodiments, the electrode system further comprises a gelconduit in fluid communication with the gel chamber and the plurality ofshell apertures.

In some embodiments, the conductive gel is housed within a bladderdisposed within the gel chamber.

In some embodiments, the fluid inlet is in fluid communication with aninternal volume of the gel chamber and an external surface of thebladder.

In some embodiments, the gel conduit is in fluid communication with thebladder.

In some embodiments, the electrode system further comprises a sealdisposed at an opening in the bladder.

In some embodiments, the bladder is disposed proximate a first end ofthe shell and the gel conduit extends from the bladder in a directiontoward a second end of the shell.

In some embodiments, the electrode system further comprises a sealdisposed within the gel conduit.

In some embodiments, the electrode system further comprises a sealdisposed between the bladder and the plurality of shell apertures.

In some embodiments, the plurality of shell apertures comprises at leastone first shell aperture disposed at a first distance from the bladderand at least one second shell aperture disposed at a second distancefrom the bladder, the second distance being greater than the firstdistance. A cross-sectional area of the at least one second shellaperture may be greater than a cross-sectional area of the at least onefirst shell aperture.

In some embodiments, the plurality of shell apertures comprises a firstpair of shell apertures, each of the first pair of shell apertures beingdisposed at the first distance from the bladder and having a samecross-sectional area.

In some embodiments, the plurality of shell apertures comprises aplurality of pairs of shell apertures disposed along a length of the gelconduit, each shell aperture of a respective pair of shell aperturesdisposed at a same distance from the bladder and having a samecross-sectional area, each respective pair of shell apertures beingdisposed at a different distance from the bladder than each other pairof shell apertures. A cross-sectional area of each shell aperture of therespective pairs of shell apertures may increase with an increaseddistance from the bladder.

In some embodiments, the gel conduit comprises a trunk and a pluralityof pairs of branches extending from the trunk, each of the plurality ofpairs of branches providing fluid communication between the trunk andone of the plurality of shell apertures. Each of the branches may have across-sectional area approximately equal to a cross-sectional area ofthe shell aperture with which the branch is in fluid communication. Thetrunk may comprise a cross-sectional area approximately equal to a sumof the cross-sectional areas of the plurality of branches.

In some embodiments, the seal is configured to rupture responsive to apressure of a fluid received at the fluid inlet.

In some embodiments, the electrode system is configured to dispense theconductive gel, responsive to a pressure of a fluid received at thefluid inlet, through the gel conduit and through the plurality of shellapertures.

In some embodiments, cross-sectional areas of the plurality of shellapertures vary along a length of the gel conduit.

In some embodiments, cross-sectional areas of the plurality of shellapertures vary along a length of the gel conduit to cause a flow rate ofthe conductive gel through each of the plurality of shell apertures tobe within about 10% of another of the plurality of shell apertures. Theplurality of shell apertures may be configured to distribute theconductive gel evenly over the second side of the shell. The pluralityof shell apertures may be configured to distribute the conductive gelevenly over a conductive layer disposed on the second side of the shell.

In some embodiments, the fluid pump is disposed on the shell and influid communication with the fluid inlet.

In some embodiments, the electrode system further comprises a conductivelayer disposed proximate to the second side of the shell.

In some embodiments, the electrode system further comprises a pluralityof conductive layer apertures defined in the conductive layer, eachrespective conductive layer aperture circumscribing a respective shellaperture of the plurality of shell apertures.

In some embodiments, the electrode system further comprises a pluralityof conductive layer apertures defined in the conductive layer, across-sectional area of each of the plurality of conductive layerapertures being greater than a corresponding cross-sectional area ofeach of the plurality of shell apertures.

In some embodiments, the electrode system is disposed in a garmentincluding a monitor, the monitor in communication with at least oneelectrical component of the electrode system. The monitor may be incommunication with the at least one electrical component of theelectrode system by an inductive coupling system including a first coildisposed on the electrode system and a second coil disposed in thegarment. The monitor may be in communication with the at least oneelectrical component of the electrode system by a capacitive couplingsystem including a first conductive plate or sheet disposed on theelectrode system and a second conductive plate or sheet disposed in thegarment. The monitor may be in communication with the at least oneelectrical component of the electrode system by an infrared signalcommunication system.

In some embodiments, the monitor is in communication with the at leastone electrical component of the electrode system by conductive hook andloop fasteners. The conductive hook and loop fasteners may maintain theelectrode system in a desired orientation relative to the garment.

In some embodiments, the monitor is in communication with the at leastone electrical component of the electrode system by conductive snaps.The conductive snaps may maintain the electrode system in a desiredorientation relative to the garment.

In some embodiments, the monitor is in communication with the at leastone electrical component of the electrode system by one or moreconductive magnets and associated conductive magnetic contacts. The oneor more conductive magnets and associated conductive magnetic contactsmay maintain the electrode system in a desired orientation relative tothe garment.

In some embodiments, the electrode system further comprises a pluralityof therapy electrodes each including a gel chamber and a fluid inlet incommunication with the gel chamber, and a common distribution node. Thefluid pump is disposed on the common distribution node and is in fluidcommunication with the fluid inlet of each of the plurality of therapyelectrodes.

In some embodiments, the electrode system further comprises a pluralityof therapy electrodes each including a gel chamber and a fluid inlet incommunication with the gel chamber and a fluid pump disposed on each ofthe plurality of therapy electrodes and in fluid communication with thefluid inlet of the therapy electrode on which it is disposed.

In some embodiments, the electrode system further comprises a pluralityof therapy electrodes including a first therapy electrode, a secondtherapy electrode, and a third therapy electrode, each of the pluralityof therapy electrodes including a gel chamber and a fluid inlet incommunication with the gel chamber, a first fluid pump disposed on afirst therapy electrode and in fluid communication with the fluid inletof the first therapy electrode, and a second fluid pump disposed on thesecond therapy electrode and in fluid communication with the fluid inletof the second therapy electrode and the fluid inlet of the third therapyelectrode.

In some embodiments, the electrode system further comprises a pluralityof therapy electrodes including a front therapy electrode having a firstconfiguration and a rear therapy electrode having a second configurationdifferent from the first configuration, each of the plurality of therapyelectrodes including a gel chamber and a fluid inlet in communicationwith the gel chamber, a first fluid pump disposed on the front therapyelectrode and in fluid communication with the fluid inlet of the fronttherapy electrode, and a second fluid pump disposed on the rear therapyelectrode and in fluid communication with the fluid inlet of the reartherapy electrode.

In some embodiments, the electrode system further comprises a pluralityof therapy electrodes including a front therapy electrode having a firstconfiguration and a rear therapy electrode having a second configurationdifferent from the first configuration, each of the plurality of therapyelectrodes including a gel chamber and a fluid inlet in communicationwith the gel chamber, and a common distribution node. The fluid pump isdisposed on the common distribution node and is in fluid communicationwith the fluid inlet of both the front therapy electrode and the reartherapy electrode.

In some embodiments, the electrode system further comprises a pluralityof therapy electrodes including a first therapy electrode, a secondtherapy electrode, and a third therapy electrode, and a monitorconfigured to monitor a physiological parameter of a subject utilizingthe therapy electrode system. The fluid pump is disposed on the monitorand is in fluid communication with each therapy electrode of theplurality of therapy electrodes through the common distribution node.

In some embodiments, the electrode system further comprises a pluralityof therapy electrodes including a front therapy electrode having a firstconfiguration and a rear therapy electrode having a second configurationdifferent from the first configuration, and a monitor configured tomonitor a physiological parameter of a subject utilizing the therapyelectrode system. The fluid pump is disposed on the monitor and is influid communication with the front therapy electrode and the reartherapy electrode through the common distribution node.

In accordance with another aspect disclosed herein there is provided anelectrode system. The electrode system comprises a plurality of therapyelectrodes. Each of the plurality of therapy electrodes includes a shelldefining a gel chamber on a first side of the shell, a bladder disposedwithin the gel chamber and housing a conductive gel, a fluid inlet influid communication with an internal volume of the gel chamber and anexternal surface of the bladder, a plurality of shell apertures definedin a second side of the shell, and a gel conduit in fluid communicationwith the bladder and the plurality of shell apertures. The electrodesystem further comprises a common distribution node. Each of theplurality of therapy electrodes is at least one of fluidly connected tothe common distribution node and electrically connected to the commondistribution node.

In some embodiments, the electrode system further comprises a fluidpressure source disposed on the common distribution node, the fluidpressure source in fluid communication with the fluid inlet of each ofthe plurality of therapy electrodes.

In some embodiments, the electrode system further comprises a fluidpressure source disposed on each of the plurality of therapy electrodesand in fluid communication with the fluid inlet of the therapy electrodeon which it is disposed.

In some embodiments, the plurality of therapy electrodes comprises threetherapy electrodes including a first therapy electrode, a second therapyelectrode, and a third therapy electrode, and the therapy electrodesystem further comprises a first fluid pressure source disposed on thefirst therapy electrode and in fluid communication with the fluid inletof the first therapy electrode, and a second fluid pressure sourcedisposed on the second therapy electrode and in fluid communication withthe fluid inlet of the second therapy electrode and the fluid inlet ofthe third therapy electrode.

In some embodiments, the plurality of therapy electrodes comprises afront therapy electrode having a first configuration and a rear therapyelectrode having a second configuration different from the firstconfiguration, and the therapy electrode system further comprises afirst fluid pressure source disposed on the front therapy electrode andin fluid communication with the fluid inlet of the front therapyelectrode, and a second fluid pressure source disposed on the reartherapy electrode and in fluid communication with the fluid inlet of therear therapy electrode.

In some embodiments, the plurality of therapy electrodes comprises afront therapy electrode having a first configuration and a rear therapyelectrode having a second configuration different from the firstconfiguration, and the therapy electrode system further comprises afluid pressure source disposed on the common distribution node, thefluid pressure source in fluid communication with the fluid inlet ofboth the front therapy electrode and the rear therapy electrode.

In some embodiments, the plurality of therapy electrodes includes afirst therapy electrode, a second therapy electrode, and a third therapyelectrode, and the therapy electrode system further comprises a monitorconfigured to monitor a physiological parameter of a subject utilizingthe therapy electrode system and a fluid pressure source disposed on themonitor and in fluid communication with the three therapy electrodesthrough the common distribution node.

In some embodiments, the plurality of therapy electrodes comprises afront therapy electrode having a first configuration and a rear therapyelectrode having a second configuration different from the firstconfiguration, and the therapy electrode system further comprises amonitor configured to monitor a physiological parameter of a subjectutilizing the therapy electrode system and a fluid pressure sourcedisposed on the monitor and in fluid communication with the fronttherapy electrode and the rear therapy electrode through the commondistribution node.

In accordance with another aspect disclosed herein, there is provided awearable monitoring device. The wearable monitoring device comprises amonitor configured to monitor a physiological parameter of a subjectutilizing the wearable monitoring device, a gel chamber included in themonitor, a bladder disposed within the gel chamber and housing aconductive gel, a fluid pressure source in fluid communication with aninternal volume of the gel chamber and an external surface of thebladder, and a plurality of therapy electrodes. Each of the plurality oftherapy electrodes includes an electrode shell, a plurality of shellapertures defined in a side of the shell, and a gel conduit in fluidcommunication with the bladder and the plurality of shell apertures. Thewearable monitoring device further comprises a common distribution node,each of the plurality of therapy electrodes being at least one offluidly connected to the common distribution node and electricallyconnected to the common distribution node.

In some embodiments, the fluid pressure source is disposed in themonitor. The plurality of therapy electrodes may include a first therapyelectrode, a second therapy electrode, and a third therapy electrode.The fluid pressure source may be in fluid communication with the threetherapy electrodes through the common distribution node. The pluralityof therapy electrodes may include a front therapy electrode having afirst configuration and a rear therapy electrode having a secondconfiguration different from the first configuration. The fluid pressuresource may be in fluid communication with the fluid conduit of both thefront therapy electrode and the rear therapy electrode.

In accordance with another aspect, there is provided an electrodesystem. The electrode system comprises a shell defining a gel chamberhousing a conductive gel, a fluid inlet in fluid communication with thegel chamber, and a plurality of apertures in fluid communication withthe gel chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are not intended to be drawn to scale. In thedrawings, each identical or nearly identical component that isillustrated in various figures is represented by a like numeral. Forpurposes of clarity, not every component may be labeled in everydrawing. In the drawings:

FIG. 1 is a schematic diagram depicting an external medical device, suchas a wearable therapeutic device, in accordance with an embodiment;

FIG. 2 is an illustration of a wearable therapeutic device, e.g., awearable defibrillator, in accordance with an embodiment;

FIG. 3A is a plan view of a receptacle for an external medical device inaccordance with an embodiment;

FIG. 3B is a view of the underside of the receptacle of FIG. 3A;

FIG. 3C is an elevational side view of the receptacle of FIG. 3A;

FIG. 3D is a cross-sectional view of a portion of the receptacle of FIG.3A;

FIG. 4 is a plan view of a receptacle for an external medical device inaccordance with an embodiment;

FIG. 5 is a plan view of a receptacle for an external medical device inaccordance with an embodiment;

FIG. 6 is a schematic illustration of a plurality of receptacles for usein embodiments of an external medical device and interconnectionsbetween the plurality of receptacles;

FIG. 7 is a schematic illustration of a plurality of receptacles for usein embodiments of an external medical device and interconnectionsbetween the plurality of receptacles;

FIG. 8 is a schematic illustration of a plurality of receptacles for usein embodiments of an external medical device and interconnectionsbetween the plurality of receptacles;

FIG. 9 is a schematic illustration of a plurality of receptacles for usein embodiments of an external medical device and interconnectionsbetween the plurality of receptacles;

FIG. 10 is a schematic illustration of a plurality of receptacles foruse in embodiments of an external medical device and interconnectionsbetween the plurality of receptacles;

FIG. 11 is a schematic illustration of a plurality of receptacles foruse in embodiments of an external medical device and interconnectionsbetween the plurality of receptacles;

FIG. 12 is a schematic illustration of a plurality of receptacles foruse in embodiments of an external medical device and interconnectionsbetween the plurality of receptacles;

FIG. 13 is a schematic illustration of a plurality of receptacles foruse in embodiments of an external medical device and interconnectionsbetween the plurality of receptacles and another component of theexternal medical device;

FIG. 14 is a schematic illustration of a plurality of receptacles foruse in embodiments of an external medical device and interconnectionsbetween the plurality of receptacles and another component of theexternal medical device;

FIG. 15 is a schematic illustration of a plurality of receptacles foruse in embodiments of an external medical device and interconnectionsbetween the plurality of receptacles and another component of theexternal medical device;

FIG. 16 is a schematic illustration of a plurality of receptacles foruse in embodiments of an external medical device and interconnectionsbetween the plurality of receptacles and another component of theexternal medical device;

FIG. 17 is a schematic diagram depicting the interface between a therapyelectrode and a subject's skin in accordance with an embodiment;

FIG. 18 is a schematic diagram depicting components of an externalmedical device in accordance with an embodiment;

FIG. 19 is a schematic diagram depicting communication between areceptacle of a wearable therapeutic device and a therapy controller ofthe wearable therapeutic device in accordance with an embodiment;

FIG. 20 is a schematic diagram depicting communication between areceptacle of an external medical device and a therapy controller of theexternal medical device in accordance with an embodiment;

FIG. 21 is a schematic diagram depicting communication between areceptacle of an external medical device and a therapy controller of theexternal medical device in accordance with an embodiment;

FIG. 22 is a schematic diagram depicting an external medical device inaccordance with an embodiment;

FIG. 23 is a schematic diagram depicting electrodes of an externalmedical device that include conductive stitching in accordance with anembodiment;

FIG. 24 is a schematic diagram depicting electrodes of an externalmedical device that include conductive stitching in accordance with anembodiment;

FIG. 25 is a schematic diagram depicting components of an externalmedical device in accordance with an embodiment; and

FIG. 26 is a schematic diagram depicting components of an externalmedical device in accordance with an embodiment.

DETAILED DESCRIPTION

Aspects and embodiments described herein are not limited in theirapplication to the details of construction and the arrangement ofcomponents set forth in the description or illustrated in the drawings.Aspects and embodiments disclosed herein are capable of being practicedor of being carried out in various ways. Also, the phraseology andterminology used herein is for the purpose of description and should notbe regarded as limiting. The use of “including,” “comprising,” “having,”“containing,” “involving,” and variations thereof herein, is meant toencompass the items listed thereafter, equivalents thereof, andadditional items, as well as alternate embodiments consisting of theitems listed thereafter exclusively.

Various aspects and embodiments are directed to systems and methods fordeploying a conductive gel in an external medical device. For example,such an external medical device can be an ambulatory monitoring and/ortreatment device such as a wearable therapeutic device. The wearabletherapeutic device can include monitoring electrodes, a therapycontroller and a plurality of therapy electrodes configured to deliverelectrical therapy, such as one or more defibrillation shocks or pacingpulses to a subject. For example, the external medical device may be awearable therapeutic device such as the LifeVest® wearable cardioverterdefibrillator available from ZOLL Medical Corporation of Chelmsford,Mass. In other examples, the external medical device may be a stationarydevice that may be utilized, for example, in a hospital setting or anautomated external defibrillator (AED).

The external medical device can be configured to house at least onereceptacle including conductive gel. For example, the receptacle may behoused within at least one therapy electrode in the device. In anexample, the receptacle may be removable or separable from the at leastone therapy electrode for replacement by a patient or service personnel.Prior to delivering an electric shock, a gel deployment control unit candirect the at least one receptacle to release the conductive gel ontothe plurality of therapy electrodes, lowering an impedance between thesubject's skin and the therapy electrodes. In some examples describedherein, the control unit can actuate a fluid pump that in turn can causethe at least one receptacle to release the conductive gel. After theconductive gel is deployed, the therapy controller can administer anelectric shock or pacing pulse to the subject via the therapy electrodesand conductive gel. The therapy electrodes can be housed in or on agarment of the external medical device.

In one example, spent receptacles can be removed from the externalmedical device and replaced with fresh receptacles that contain at leastone dose of conductive gel. For example, the spent receptacles can bereplaced when the external medical device is returned to a servicecenter for servicing and/or refurbishing.

FIG. 1 is a schematic diagram of an external medical device 100 inaccordance with an embodiment. In one embodiment, external medicaldevice 100 includes a garment 105. Garment 105 may be similar to thegarment disclosed in commonly owned U.S. Pat. No. 9,008,801, titled“WEARABLE THERAPEUTIC DEVICE,” which issued on Apr. 14, 2015, thedisclosure of which is incorporated herein by reference in its entirety,or in commonly owned U.S. patent application Ser. No. 13/460,250, titled“PATENT-WORN ENERGY DELIVERY APPARATUS AND TECHNIQUES FOR SIZING SAME,”filed on Apr. 30, 2012, the disclosure of which is incorporated hereinby reference in its entirety.

In one embodiment garment 105 includes a belt 110. Belt 110 may be wornabout a subject's waist, at a higher location about the subject's chest,or at other locations between the subject's waist and shoulders.Components of external medical device 100 can be worn under, over, orpartially under and partially over a subject's clothes.

The external medical device 100 includes the following elements: garment105, including belt 110, therapy controller 115, alarm module 120,monitor 125, gel deployment control unit 130, first therapy electrode135, second therapy electrode 140, receptacles 1145 in or proximate eachof the therapy electrodes 135, 140, one or more cardiac sensingelectrodes 150, which may each also include or be disposed proximate areceptacle 1145 (as shown in dotted lines), shoulder strap 155, andholster 160. First therapy electrode 135 may include at least one fronttherapy electrode and second therapy electrode 140 may include at leastone rear therapy electrode. In one embodiment, at least one of therapycontroller 115, alarm module 120, monitor 125, gel deployment controlunit 130, at least one front therapy electrode 135, at least one reartherapy electrode 140, receptacle 1145, at least one sensing electrode150, shoulder strap 155, and/or holster 160 can be included in orattached to belt 110. In an implementation, the at least one reartherapy electrode 140 can further include at least two rear therapyelectrodes as shown in FIG. 2 . In some examples, at least one of alarmmodule 120 and monitor 125 can be fitted to open or closed pockets ofbelt 110 or garment 105 or otherwise attached to belt 110 or garment 105via buttons, hook and loop fasteners, straps, snaps, magnets, orsleeves, or another attachment mechanism that forms part of belt 110 orgarment 105. These elements may also be integrated into belt 110 orgarment 105, and as such, may be a permanent part of belt 110 or garment105. In some examples, the alarm module 120 can be integrated into and apart of the monitor 125. External medical device 100 may include theabove mentioned elements, as well as additional elements.

FIG. 2 is an illustration of an embodiment of the external medicaldevice 100 with the electrode components shown removed from the garment.As depicted in FIG. 2 , the therapy controller 115, the alarm module120, and the monitor 125 can be integrated into a portable medicaldevice control unit 165 that can be attached to the garment 105.

Therapy controller 115 is included in garment 105. Therapy controller115 can be attached to shoulder strap 155, or disposed in holster 160.Holster 160 may attach to or be part of garment 105, shoulder strap 155,or belt 110. In some implementations, therapy controller 115, alarmmodule 120, and monitor 125 are combined into a single medical devicecontrol unit 165 that may be attached to or carried in the garment 105.Therapy controller 115 is electrically coupled to first therapyelectrode 135 and second therapy electrode 140. In some embodiments,therapy controller 115 is also electrically coupled to one or moresensing electrodes 150. Each of electrodes 135, 140 has an associatedreceptacle 1145. In one embodiment, therapy controller 115 may includethe defibrillator described in commonly owned U.S. Pat. No. 6,280,461,titled “PATENT-WORN ENERGY DELIVERY APPARATUS,” which issued on Aug. 28,2001, and which is incorporated by reference herein in its entirety.

Monitor 125 or control circuitry of therapy controller 115 monitors asubject's condition. For example, the one or more sensing electrodes 150can sense electrical activity of the subject's heart signals. When anarrhythmic event is detected, alarm module 120 sounds a warning that thesubject wearing external medical device 100 is in danger of, or isexperiencing, a heart attack, cardiac arrest, or other form of cardiacdistress. This warning may be audio, visual, haptic (e.g., vibratingalarm module 120) or combinations thereof. The signals sensed by the oneor more sensing electrodes 150 can be displayed as electrocardiographsignals on monitor 125. This and other information can be stored inmemory units associated with monitor 125 or therapy controller 115 foranalysis by a doctor, rescuer, or health care provider.

Alarm module 120 may provide an alarm that indicates that the subjectwill receive a defibrillation shock from therapy controller 115delivered by the first therapy electrode 135 and second therapyelectrode 140 unless the subject wearing external medical device 100takes some action to prevent therapy controller 115 from applying theshock. For example, alarm module 120 or monitor 125 may include a userinterface having at least one button or touch screen. In this example,the subject can depress the at least one button to indicate that thesubject is conscious. In this example, the defibrillation shock will notbe applied while the subject depresses the at least one button for asufficient amount of time, or if control logic of therapy controller 115determines that the electrical heart activity of the subject (asdetected by sensing electrode 150) has returned to normal. Continuingwith this example, if the subject loses consciousness, the subject willrelease the at least one button and therapy controller 115 will apply adefibrillation shock via the first therapy electrode 135 and secondtherapy electrode 140.

First therapy electrode 135 includes at least one front therapyelectrode positioned in garment 105 in front (e.g., anterior or aboutthe chest) of the subject, and second therapy electrode 140 includes atleast one therapy electrode positioned in garment 105 at the rear (e.g.posterior or about the back) of the subject. Other anterior, posterior,and lateral positioning with respect to the subject when the subject iswearing garment 105 is possible. For example, first therapy electrode135 and second therapy electrode 140 may both be in an anterior positionwith respect to the subject. In one embodiment, multiple therapyelectrodes are disposed in an anterior position. Multiple therapyelectrodes may also be disposed in any position, e.g., anterior,posterior, or lateral.

In one embodiment, first therapy electrode 135 and second therapyelectrode 140 may be permanent components of external medical device100. Electrodes 135 and 140 can be housed anywhere in garment 105. Forexample, first therapy electrode 135 can be integral to garment 105 anddisposed proximate to the subject's chest or abdomen when the subject iswearing external medical device 100. Second therapy electrode 135 can beintegral to garment 105 and disposed proximate to the subject's backwhen the subject is wearing external medical device 100. In oneembodiment, when a shock is applied, first therapy electrode 135, secondtherapy electrode 140, the subject's body, and therapy controller 115form at least part of a current path for the shock. In some embodiments,for example, as illustrated in FIG. 2 , electrodes 135, 140, and 150 maybe coupled to a common distribution node 1250, described in more detailbelow. An electrical connector 1255 may electrically connect the commondistribution node 1250 to a monitor 125.

Configuration of Conductive Gel Receptacles

An example receptacle 1145 that can be used with embodiments of theexternal medical device 100 is shown in FIGS. 3A-D. A person of ordinaryskill in the art will appreciate that the example receptacle 1145 shownin FIGS. 3A-D is for illustration only and does not limit the claims.For example, receptacle 1145 can include a shell 1140 (see FIG. 3C)having an upper portion defining an upper surface 1150 of the receptacle1145 and a lower portion defining a lower surface 1155 of the receptacle1145. In some embodiments, such as illustrated in FIG. 3B, the lowersurface 1155 can be at least partially covered with a conductive layer1160 to form a therapy electrode (e.g., for use as one of therapyelectrodes 135, 140). The conductive layer 1160 can be formed from, forexample, a layer of metal adhered to the lower surface 1155. The layerof metal may include, for example, tin, silver, stainless steel, orother metals, metal oxides, or mixtures thereof. In some embodiments,the layer of metal may be replaced or supplemented with a non-metallicconductive material, for example, a conductive polymer, carbon fiber, amaterial including conductive particles dispersed in it, or any othermaterial that is electrically conductive and that may also bebiocompatible and/or corrosion resistant.

In some examples, the receptacle 1145 and conductive layer 1160 can forma monitoring/sensing electrode for detecting a signal (e.g., a cardiacsignal) from the patient. In some examples, the receptacle 1145 caninclude one or more conductive layers and/or sensors for performing bothmonitoring/sensing a patient signal and providing a therapeutictreatment.

One or more electrical connectors (not shown) can electrically connectthe conductive layer 1160 to the therapy controller 115 to enable it tofunction as one of the therapy electrodes 135, 140 of embodiments of theexternal medical device disclosed herein. In other embodiments, thereceptacle 1145 may not include conductive layer 1160 and the receptacle1145 may be configured to dispense conductive gel onto or proximate to atherapy electrode that is formed separately from the receptacle 1145. Insome embodiments, the receptacle 1145 may be removably attached to thetherapy electrode 135, 140 (e.g., by being at least removably attachedto the conductive layer 1160).

In one example, a gel chamber 1105 can be defined in an upper portion ofthe shell of the receptacle 1145 for containing the conductive gel (notshown). In use, when a defibrillation shock is to be applied to asubject wearing a wearable therapeutic device including the receptacle1145, an external pressure can be applied to the conductive gel throughthe use of an external pressure source or a pressure source device. Forexample, the pressure can be applied to the internal volume of the gelchamber 1105. In some implementations, the pressure source can be afluid pump (e.g., an air pump) as described in further detail below. Forexample, the fluid can be physically separated from the conductive gelby a membrane such that pressure applied by the fluid on one side of themembrane can cause the conductive gel that is disposed on the other sideof the membrane to be deployed.

In some implementations, the conductive gel can be contained within abladder 1110 (see FIG. 3D) disposed within the gel chamber 1105. In someexamples, the gel chamber 1105 and/or the bladder 1110 can include amechanism for separating the gel from the rest of the delivery system(e.g., the gel conduit 1165) that can be configured to allow a flow ofthe gel from the gel chamber and/or bladder 1110 once a pressurethreshold is reached or exceeded as described below. For example, such amechanism can include a seal 1115. The pressure can build up in the gelchamber 1105 and can cause the seal 1115 to rupture at, for example,about 15 psig. In some examples, the seal can be configured to releasethe gel at any pressure value in a range of 10-20 psig. A person ofordinary skill in the art will recognize that the range of valuesprovided herein is for illustration only and, in some examples, valuesabove or below this range may be used. For example, the pressure rangecan be increased to a range of 20-30 psig and still be in accordancewith the concepts described herein. Further, while seal 1115 is shown tobe disposed at a location between gel chamber 1105 and a gel conduit1165, it should be understood that seal 1115 can be placed anywherewithin gel conduit 1165 on or in the receptacle 1145, for example,defined in the top portion of the receptacle 1145 as shown in FIG. 3A,and/or within the gel chamber 1105 and/or on the bladder 1110.

When seal 1115 ruptures, the conductive gel contained within bladder1110 flows through a main trunk 1170 of the gel conduit 1165, throughbranches 1175 of the gel conduit 1165, and through shell apertures 1180defined in the lower portion of the shell to provide a conductive pathbetween a therapy electrode 135, 140 and a body of a subject wearing theexternal medical device 100. In some examples, the external pressuresource can cause pressure to be applied for a predetermined duration toreach the threshold (e.g., 10-20 psig) necessary for causing the seal1115 to rupture and further ensuring that substantially all or at leasta significant amount of the conductive gel is deployed. In someembodiments, the pressure can be applied until all conductive gel fromthe gel chamber 1105 and/or bladder 1110 is dispensed through the shellapertures 1180. For example, depending on a location of the pressuresource, the pressure can be applied for approximately 10 seconds(generally in a range of 2-15 seconds) before the pressure source isturned off. In some examples, a sensing circuit (as described below) candetect if a desired impedance value is reached and cause the pressuresource device to be turned off responsive to the desired impedance valuehaving been reached.

In other embodiments, some conductive gel may remain, for example,within one or more portions of the gel conduit 1165 after the receptacle1145 is activated to dispense the conductive gel.

In some embodiments, the bladder 1110 is not included within the gelchamber 1105 and the conductive gel may be disposed in direct contactwith internal surfaces of the gel chamber 1105. As such, the fluid fromthe fluid pump may directly contact the conductive gel. In otherembodiments, the gel chamber 1105 need not be defined in the upperportion of the shell of the receptacle 1145. For example, the gelchamber 1105 may straddle the upper and lower portions of the shell. Inother embodiments, the gel chamber 1105 need not even be defined on orin the shell of the receptacle 1145, but may be disposed separate fromthe receptacle 1145, for example, on a separate receptacle 1145 or on orin another component of the external medical device 100. In someexamples, the bladder 1110 may be only partially disposed within the gelchamber 1105 (or even the receptacle 1145) and as such a portion of thebladder 1110 may be disposed external to the gel chamber 1105 (orreceptacle 1145).

A source of the external pressure that is applied to bladder 1110 withingel chamber 1105 may be a gas cartridge as disclosed in commonly ownedU.S. Pat. No. 8,406,842, titled “ELECTRODE WITH REDUNDANT IMPEDANCEREDUCTION,” which issued on Mar. 26, 2013, and which is incorporatedherein by reference in its entirety. Alternatively, the source ofpressure can be a fluid pump 1200 (see FIG. 4 ) which may be disposed tobe either part of the therapy electrode 135, 140, or to be external tothe receptacle 1145, for example, disposed on or in the monitor 125 oron another portion of the belt 110 or garment 105 as described furtherbelow. For example, the fluid pump can be implemented within or in theform of a removable cartridge. After the gel is deployed, the spentcartridge can be removed and replaced with a new cartridge.

In some embodiments, the fluid pump 1200 is an air pump. The fluid pump1200 may receive or intake a fluid, for example, air, at a firstpressure and output the fluid at a second pressure higher than the firstpressure by, for example, between about 10 psig (about 69 kPa gauge) andabout 20 psig (about 138 kPa gauge). In some embodiments, the fluid pump1200 may include a model KPM27H miniature air pump, or one of the otherminiature air pumps available from Koge Electronics Co., Ltd. The fluidpump 1200 may have dimensions of about 2.72 in×1.46 in×1.18 in (6.9cm×3.7 cm×3.0 cm). The fluid pump 1200 utilized in embodiments disclosedherein, however, is not limited to a KPM27H miniature air pump. Anyfluid or air pressure pump capable of providing sufficient pressure tocause release of the conductive gel from a receptacle 1145 may beutilized.

The fluid pump 1200 provides pressurized fluid, for example, air to theinternal volume of the gel chamber 1105 and/or to an external surface ofthe bladder 1110 within the gel chamber 1105 through a fluid conduit ortube fluidly connecting an output of the fluid pump 1200 with a fluidinlet 1185 disposed on the receptacle 1145, for example, on the upperportion of the receptacle 1145 as shown in FIG. 3A. In some embodimentsan intermediate chamber or conduit may be provided between the fluidpump 1200 and fluid inlet 1185 and/or between the fluid inlet 1185 andthe gel chamber 1105. The fluid pump 1200, in some embodiments, providesa pressure of between about 10 psig and about 15 psig to the internalvolume of the gel chamber 1105 and/or external surface of the bladder1110. As detailed above, this pressure range can be varied to be higheror lower than 10-15 psig. For instance, the range can be selected to be15-30 psig.

In some examples, the source of external pressure (the “fluid pressuresource”) can be in the form of a plunger mechanism disposed within abarrel (e.g., cylindrical or any other shape), such as in a syringe. Insuch cases, the conductive gel can be disposed within the barrel (ortube). When the plunger is actuated, e.g., by a mechanism activated inaccordance with the principles described herein, the gel can be expelledfrom within the barrel or tube. For example, a seal can be placed overan orifice at an open end of the tube. When the plunger is actuated, theseal can be ruptured as described herein, and the conductive gel can bereleased. For example, a syringe pump can be activated to releaseconductive gel in accordance with the concepts described herein.

In some examples, a different fluid can be disposed within the barrel toserve as a working fluid in applying pressure directly or indirectly tothe conductive gel. For example, the conductive gel can be disposedwithin a bladder (such as bladder 1110). The working fluid can beexpelled via the orifice in the syringe such that the resultant pressureis applied directly to the conductive gel or, e.g., through a wall ofthe bladder 1110, if the gel is disposed within the bladder 1110.

For example, the syringe pump can be implemented within or in the formof a removable cartridge. After the gel is deployed, the spent cartridgecan be removed and replaced with a new cartridge.

In some implementations, the external pressure source can be aperistaltic pump. For example, such a pump can include a rotarymechanism having rollers (or “lobes”) for compressing or pinching closeda flexible, circular tube inside a circular pump casing. In someexamples, apart from or in addition to a circular peristaltic pump, alinear peristaltic pump can be employed for a same or similar effect. Insome examples, the fluid in the pump can be the conductive gel. In otherexamples, the fluid can be a working fluid which can be used to applypressure directly or indirectly to the conductive gel in accordance withthe principles described herein. For example, the peristaltic pump canbe implemented within or in the form of a removable cartridge. After thegel is deployed, the spent cartridge can be removed and replaced with anew cartridge.

In some embodiments, the receptacle 1145 includes a plurality of shellapertures 1180. For example, the apertures 1180 can be sized andspatially distributed to cause the gel to be substantially evenlydistributed over the area of contact of the therapy electrode with thepatient's skin. An example of such sizing and spacing is shown below. Itshould be understood, however, that other patterns and/or distributionsof shell apertures 1180 can be used to similarly result in asubstantially even distribution of the conductive gel.

For example, the receptacle 1145 illustrated in FIG. 3B includes tenshell apertures 1180. More or fewer shell apertures 1180 may beprovided. As shown in FIG. 3B the shell apertures 1180 may be arrangedin pairs, specifically, five pairs of shell apertures 1180.

As shown, each shell aperture 1180 in a pair of shell apertures 1180 isdisposed at a common distance from a first end 1145′ and second end1145″ of the receptacle and from the gel chamber 1105 and/or bladder1110. Each shell aperture 1180 in a pair of shell apertures 1180 has acommon length and/or volume of gel conduit 1165 between the shellaperture 1180 and the gel chamber 1105 and/or bladder 1110.

The shell apertures 1180 are sized such that upon dispensing of theconductive gel from the receptacle 1145, a substantially same amount ofconductive gel flows through each of the shell apertures 1180. Forexample, in some embodiments, the shell apertures 1180 are sized suchthat upon dispensing of the conductive gel from the receptacle 1145 arate and/or an amount of gel dispensed through any shell aperture 1180is between about 1% and 20%, for example, within about 10%, of a rateand/or amount of conductive gel dispensed through any other of the shellapertures 1180. To accomplish this, the shell apertures 1180 may beconfigured to increase in cross-sectional area or diameter withincreasing distance from the gel chamber 1105 and/or bladder 1110. Insome implementations, each shell aperture 1180 in a pair of shellapertures 1180 located at a same or similar distance from the gelchamber 1105 and/or bladder 1110 may have a same or similarcross-sectional area or diameter. For example, in some cases, eachaperture in a pair of apertures 1180 may have a cross-sectional areathat is within about 2% of a cross-sectional area of the other aperturein the pair of apertures 1180.

In a specific, non-limiting example, the shell apertures 1180A closestto the gel chamber 1105 and/or bladder 1110 have a diameter of about0.051 inches (0.13 cm) and the shell apertures 1180B furthest from thegel chamber 1105 and/or bladder 1110 have a diameter of about 0.067inches (0.17 cm). The branches 1175 of the gel conduit 1165 have similaror the same cross-sectional areas as the respective shell apertures 1180at which they terminate and thus, as shown in FIG. 3A, thecross-sectional area of the branches 1175 increase with increasingdistance from the gel chamber 1105 and/or bladder 1110. The main trunk1170 of the gel conduit 1165 has a cross-sectional area about equal tothe sum of the cross-sectional areas of each of the branches 1175.

In embodiments of receptacles 1145 including a conductive layer 1160,the conductive layer 1160 includes a plurality of conductive layerapertures 1190 corresponding to the shell apertures 1180. In someimplementations, there may be a one-to-one correspondence between shellapertures 1180 and conductive layer apertures 1190. For example, eachconductive layer aperture 1190 circumscribes a single shell aperture1180. Each conductive layer apertures 1190 has a diameter and/orcross-sectional area greater than that of the shell aperture 1180 thatit circumscribes so as not to interfere with the passage of conductivegel through the shell aperture 1180. In some embodiments, eachconductive layer aperture 1190 has a similar or same diameter and/orcross-sectional area as each other conductive layer aperture 1190.

Example Alternative Gel Deployment Apparatus

In some implementations, the gel deployment apparatus can include aplurality of tubes (or a single main tube comprises a plurality ofbranch tubes) disposed on a flexible frame in a predeterminedarrangement. For example, the one or more tubes can be arranged to carryconductive gel from a gel chamber (e.g., located in the monitor) anddispense the gel substantially evenly over a surface of the patient'sskin that is in contact with a conductive surface of a therapyelectrode. For example, the tubes can be configured to be distributed inthe form of pairs of tubes branching out on either side of a centralline of the frame (e.g., in a manner similar to the arrangement shownfor FIGS. 3A-3D). For example, the plurality of tubes can comprise fiveor more pairs of tubes arranged to be distributed along a length of theframe. In some implementations, a cross-sectional area or a diameter ofthe tubes can vary in a similar manner as described above.

For example, tubes may be sized such that upon dispensing of theconductive gel, a substantially same amount of conductive gel flowsthrough each of the tubes. For example, in some embodiments, the tubesmay be sized such that upon dispensing of the conductive gel a rateand/or an amount of gel dispensed through any tube is between about 1%and 20%, for example, within about 10%, of a rate and/or amount ofconductive gel dispensed through any other tube. To accomplish this,tubes may be configured to increase in cross-sectional area or diameterwith increasing distance from a gel chamber. In some implementations,each tube in a pair of tubes located at a same or similar distance froma gel chamber may have a same or similar cross-sectional area ordiameter. For example, in some cases, each tube in a pair of tubes mayhave a cross-sectional area that is within about 2% of a cross-sectionalarea of the other tube in the pair of tubes.

In some examples, the gel chamber in communication with the tubes (alongwith the tubes and the associated gel deployment circuitry) can beimplemented within or in the form of a removable cartridge that isdisposed within any of the monitor, distribution node, and/or one ormore electrodes. In some implementations, only the gel chamber may bewithin the removable cartridge so that the associated gel deploymentcircuitry can be reused and not discarded. After the gel is deployed,the spent cartridge can be removed and replaced with a new cartridge.

Example Conductive Gel Activation Mechanisms

In an embodiment, for example, as illustrated in FIG. 4 , a pressuresource (e.g., fluid pump 1200) is incorporated on one or more of thetherapy electrodes 135, 140 themselves (rather than in, e.g., thedistribution node or the monitor). It should be understood that anyother pressure sources and/or mechanisms described above may be used(e.g., a syringe or a peristaltic pump).

Fluid pump 1200 can be coupled to or mounted on a portion of thereceptacle 1145, for example, on the upper surface 1150 of thereceptacle 1145 or an extension thereof. The fluid pump 1200 may befluidly coupled by a fluid pressure conduit 1205 to the fluid inlet 1185or directly to the internal volume of the gel chamber 1105. In someembodiments, the fluid pump 1200 is removably coupled to the receptacle1145 so that the fluid pump 1200 may be reused with a differentreceptacle 1145 upon failure of a first receptacle 1145 to which it iscoupled and/or after activation of the first receptacle 1145 if thefirst receptacle 1145 is a single use receptacle 1145.

Receptacle 1145 can include various sensors and/or electrical and/orelectronic components for causing deployment of the conductive gel anddetecting the event of gel deployment, a quantity of gel deployed,and/or a measure of a change in impedance caused by the gel deployment.For example, the receptacle 1145 may include a gel deployment controlunit 1130 including an activator circuit 1230. Activator circuit 1230may receive an activation signal from, for example, therapy controller115 or monitor 125 indicating that the receptacle 1145 should releaseconductive gel. Responsive to receipt of the activation signal,activator circuit 1230 may send current from, for example, a battery1215 located on the receptacle 1145 or elsewhere on or in the externalmedical device 100, to the pressure source 1200 (e.g., the fluid pump)to pressurize the gel chamber 1105 and/or bladder 110, cause the seal1115 to rupture, and cause the release of conductive gel from receptacle1145.

In some embodiments, receptacle 1145 further includes a sensing circuit1225. Sensing circuit 1225 may include functionality to determine andprovide an indication, for example, via monitor 125, of whether thetherapy electrode 135, 140 is functional, properly connected, and/orproperly aligned in garment 105. For example, such a sensing circuit1225 can be one or more orientation circuits described in commonly ownedU.S. Pat. No. 9,007,216, titled “WEARABLE THERAPEUTIC DEVICE,” whichissued on Apr. 14, 2015, the disclosure of which is incorporated hereinby reference in its entirety.

Sensing circuit 1225 may additionally or alternatively be configured tocommunicate with a pressure sensor 1220 disposed on receptacle 1145 orexternal to receptacle 1145 to make a determination as to whetherportions of receptacle 1145, for example, gel conduit 1165 and/orbladder 1110 and/or gel chamber 1105 are intact. Pressure sensor 1220may be configured to monitor the pressure in one or more portions of thereceptacle 1145, for example, in the gel conduit 1165 and/or bladder1110 and/or gel chamber 1105 to monitor for faults. For example, the gelconduit 1165 and/or bladder 1110 and/or gel chamber 1105 may be at leastpartially evacuated or pressurized. A rupture in the gel conduit 1165and/or bladder 1110 and/or gel chamber 1105 may result in a pressurechange in the gel conduit 1165 and/or bladder 1110 and/or gel chamber1105 which may be sensed by the pressure sensor 1220. The pressuresensor 1220 may provide an indication of the error condition to one ormore other components of the wearable therapeutic device, for example,sensing circuit 1225 and/or alarm module 120, and/or monitor 125. Insome examples, the control unit 1130 can determine if a receptacle 1145needs to be replaced, for example, if sensing circuit 1225 receives asignal from pressure sensor 1220 indicative of the conductive gel havingbeen released or the gel conduit 1165 or bladder 1110 and/or gel chamber1105 having been ruptured.

In some embodiments, one or more functions of gel deployment controlunit 1130 may be alternatively be performed by a control unit 130disposed external to receptacle 1145 in a portion of the garment 105,for example in monitor 125 or therapy controller 115. For example, asillustrated in FIG. 5 , receptacle 1145 may be free of electroniccomponents but include a pressure source (e.g., fluid pump 1200).

Embodiments of the receptacle 1145 may also include a connection port1210. The connection port 1210 provides for communication betweenelectrical and/or electronic components of the receptacle 1145, forexample, any one or more of the control unit 1130, sensing circuit 1225,activator circuit 1230, and pressure sensor 1220 and components of thegarment, for example, therapy controller 115, alarm module 120 and/ormonitor 125. In some embodiments, power is provided through theconnection port 1210 from an external source, for example, a batterylocated in a portion of the garment 105 to power components of thereceptacle 1145 and/or charge the battery 1215 as needed. The connectionport 1210 may include a winding of an induction coil that provideselectromagnetic connection with components of the garment, for example,alarm module 120 and/or monitor 125 through a complementary winding ofthe induction coil disposed on or in the garment 105.

In other embodiments, the connection port 1210 may include one or moreconnectors, for example, one or more conductive snaps and/or conductivehook and loop fasteners and/or conductive magnets and conductivemagnetic contacts having complimentary portions disposed on thereceptacle 1145 and the garment 105 to form an electromechanical and/orelectrical connection between receptacle 1145 and garment 105 andprovide a communication pathway between one or more components of thereceptacle 1145 and one or more components of the garment 105. Theconnector(s) may facilitate or further help ensure proper alignment ofthe receptacle 1145 within the garment 105. If the receptacle 1145 isnot properly aligned with the garment 105, the connector(s) on thereceptacle 1145 will not be able to properly couple to the complementaryconnector(s) in the garment 105, and an indicator of improper alignmentmay be provided, for example, via monitor 125. In some embodiments,alternative or additional wired or wireless means, for example, one ormore RF or infrared transmitters, receivers, or transceivers havingcomplimentary components located in the garment 105 and in thereceptacle 1145 may be utilized to provide communication between one ormore components of the receptacle 1145 and one or more components of thegarment 105. In some embodiments, conductive plates, sheets, or films,for example, metallic plates, sheets, or films in the garment 105 and inthe receptacle 1145 may be utilized to provide communication viacapacitive coupling between one or more components of the receptacle1145 and one or more components of the garment 105.

In some embodiments, in addition to or as an alternative to receptacles1145, external medical device 100 may include one or more receptacles145 as disclosed in commonly owned U.S. Pat. No. 9,008,801 disposedproximate respective therapy electrodes.

Arrangement and Interconnection of Conductive Gel Receptacles

In some embodiments, multiple receptacles 1145 in embodiments of thedisclosed external medical device 100 are coupled to one another and/orto a common distribution node by one or more signal lines and/or fluidpressure conduits and/or gel conduits. The common distribution node maybe included in various portions of the garment 105, for example, themonitor 125 or gel deployment control unit 130 or on one of thereceptacles 1145, or may be a dedicated unit disposed, for example, onthe belt 110 or other part of the garment 105. The common distributionnode may provide communication between the receptacles 1145, forexample, one or more electrical or electronic components of thereceptacles, and one or more components of the garment 105, for example,alarm module 120 and/or monitor 125. The signal lines can includeelectrical conductors electrically connected to any of the embodimentsof the connection port 1210 described above. The signal lines may beutilized to transfer communication signals between components of theexternal medical device and/or may be utilized to conduct current toreceptacles 1145 that are included in therapy electrodes 135, 140 of theexternal medical device, for example, to deliver a defibrillation shockor pacing pulses to a subject. In embodiments where a receptacle 1145does not contain any electrical components and is not part of a therapyelectrode, the receptacle 1145 may not have any signal line connected toit. Features, for example, fluid pressure source(s) and/or electrical orelectronic components (e.g., gel deployment control unit 1130, sensingcircuit 1225, activator circuit 1230 pressure sensor 1220, and/orbattery 1215) may be shared among the multiple receptacles 1145.

For example, as illustrated in FIG. 6 a system includes two rearreceptacles 1145R and one front receptacle 1145F coupled to a commondistribution node 1250 by signal lines 1260. Each receptacle 1145R,1145F includes its own gel chamber 1105 and pressure source, forexample, fluid pumps 1200. It should be understood that in the exampleillustrated in FIG. 6 and those examples that follow the pressure sourceis not limited to a fluid pump 1200, but may be any fluid pressuresource known in the art. Although illustrated as including embodimentsof receptacle 1145, it should be appreciated that the embodimentillustrated in FIG. 6 as well as those illustrated in FIGS. 8-15 may beimplemented with one or more of receptacles 1145 replaced withembodiments of receptacles 145 as disclosed in commonly owned U.S. Pat.No. 9,008,801, including multiple doses of conductive gel. For example,as illustrated in FIG. 7 , the receptacles 1145R, 1145F of FIG. 6 may besubstituted with receptacles 1146R, 1146F, respectively, which includemultiple doses or reservoirs 205 of conductive gel. Receptacles 1146R,1146F may be similar to embodiments of receptacles 145 as disclosed incommonly owned U.S. Pat. No. 9,008,801 and/or may include embodiments ofgel capsules as disclosed in commonly owned U.S. patent application Ser.No. 13/314,799, titled “THERAPEUTIC DEVICE INCLUDING ACOUSTIC SENSOR,”filed Jun. 25, 2014, the disclosure of which is incorporated herein byreference in its entirety.

FIG. 8 illustrates a system in which each receptacle 1145R, 1145Fincludes its own gel chamber 1105, but share a common fluid pump 1200.The fluid pump is disposed on the common distribution node 1250 and isin fluid communication with the gel chambers 1105 on each receptacle1145R, 1145F through fluid pressure conduits 1265. Signal lines 1260 mayalso be provided, for communicating defibrillation and/or pacing pulses,as well as other electrical signals between components of the garment105 and the receptacles 1145F, 1145R and/or between receptacles 1145F,1145R and/or common distribution node 1250.

In the example shown in FIG. 9 , each receptacle 1145R, 1145F includesits own gel chamber 1105. The front receptacle 1145F includes its ownfluid pump 1200. The rear receptacles 1145R share a common fluid pump1200 mounted on one of the rear receptacles 1145R. A fluid pressureconduit 1265 allows for the fluid pump 1200 to deliver pressurized airto the gel chamber 1105 of the rear receptacle 1145R that it is notmounted on. Signal lines 1260 provide communication between the commondistribution node 1250, the front receptacle 1145F, and the rearreceptacles 1145R.

FIG. 10 illustrates a system similar to FIG. 9 , but wherein there is nofluid pump 1200 located on either of the rear receptacles 1145R. Rather,a single fluid pump 1200 is provided on the front receptacle 1145F. Thefluid pump 1200 provided on the front receptacle 1145F controls releaseof conductive gel from each of the receptacles 1145F, 1145R. The rearreceptacles 1145R may be considered “slave” receptacles controlled byfront receptacle 1145F, which may be considered a “master” receptacle inthe example of FIG. 10 . Signal lines 1260 and fluid pressure conduits1265 provide electrical and fluid communication, respectfully, betweenthe front receptacle 1145F and the rear receptacles 1145R by way of thecommon distribution node 1250.

It should be appreciated that instead of the fluid pressure conduits1265 and/or signal lines 1260 being routed through the commondistribution node 1250, the fluid pressure conduit(s) 1265 and/or signalline(s) 1260 from the front receptacle 1145F may be directly coupled tothe fluid inlet or a signal input, respectively, of one or both of therear receptacles 1145R.

In other embodiments, any one of the receptacles may be a “master”receptacle and the other receptacles may be “slave” receptacles. Thefront receptacle 1145F and two rear receptacles 1145R can be connectedas a group, with one of the three of receptacles containing the fluidpump 1200. Two of the receptacles can be in a “slave” relationship tothe receptacle containing the fluid pump 1200 (the “master” receptacle).In some embodiments, each of the three receptacles can contain their owngel chambers 1105. As such, the fluid pump 1200 can cause force fluid(e.g., air) through conduits that are in fluid connection with the gelchambers 1105.

In some examples, the “master” receptacle can include a gel chamber 1105in communication with apertures on all three receptacles. In thisconfiguration, the gel deployment electronics as described herein cancause the fluid pump 1200 to deploy the gel through the apertures on allthree receptacles. For example, the gel chamber on the “master”receptacle can be fluidly connected through a gel conduit to theapertures of the “slave” receptacles. In this scenario, the gel can bedirected from the gel chamber 1105 on the “master” receptacle throughthe gel conduit and released from the apertures in each of thereceptacles. In some implementations, after treatment, each of the“slave” receptacles can be user-replaceable (or replaceable duringservicing), while the “master” receptacle may be retained.

In the example shown in FIG. 11 , the two rear receptacles 1145R shownin FIG. 9 have been combined into a single larger rear receptacle 1145R′with a single larger gel chamber 1105 and the fluid pressure conduit1265 has been eliminated. The front receptacle 1145F includes its owngel chamber 1105 and fluid pump 1200. Signal lines 1260 providecommunication between the common distribution node 1250, the frontreceptacle 1145F, and the rear receptacle 1145R′.

The example illustrated in FIG. 12 includes a single larger rearreceptacle 1145R′ and a front receptacle 1145F, each with its own gelchamber 1105. The receptacles 1145R′ and 1145F share a common fluid pump1200 mounted on the common distribution node 1250 and fluidly connectedto the gel chambers 1105 of the receptacles 1145R′ and 1145F throughfluid pressure conduits 1265. Signal lines 1260 may also be provided forcommunicating defibrillation and/or pacing pulses, as well as otherelectrical signals, between components of the garment 105 and thereceptacles 1145F, 1145R′ and/or between receptacles 1145F, 1145R′and/or common distribution node 1250.

The example illustrated in FIG. 13 includes a single larger rearreceptacle 1145R′ and a front receptacle 1145F, each with its own gelchamber 1105. The receptacles 1145R′ and 1145F share a common fluid pump1200 mounted on a separate component of the garment 105, for example,the monitor 125. The fluid pump 1200 is fluidly connected to the gelchambers 1105 of the receptacles 1145R′ and 1145F through fluid pressureconduits 1265 and through the common distribution node 1250. Signallines 1260 may also be provided, for communicating defibrillation and/orpacing pulses, as well as other electrical signals between components ofthe garment 105, for example, monitor 125 and the receptacles 1145F,1145R′ and/or between receptacles 1145F, 1145R′ and/or commondistribution node 1250.

The example illustrated in FIG. 14 is similar to that illustrated inFIG. 13 , with the single larger rear receptacle 1145R′ split into twosmaller sized receptacles 1145R. A fluid pressure conduit 1265 fluidlycouples the receptacles 1145R so that pressurized air from the fluidpump 1200 can reach the gel chambers 1105 of both of the receptacles1145R. Signal lines 1260 may also be provided, for communicatingdefibrillation and/or pacing pulses, as well as other electrical signalsbetween components of the garment 105, for example, monitor 125 and thereceptacles 1145F, 1145R and/or between receptacles 1145F, 1145R and/orcommon distribution node 1250.

In the example shown in FIG. 15 , none of the receptacles 1145F, 1145Rincludes its own fluid pump 1200 or gel reservoir 1105. Rather, a commonfluid pump 1200 and large gel reservoir 1105 are disposed on a separatecomponent of the garment 105, for example, the monitor 125. Conductivegel is directed into each of the receptacles 1145F, 1145R from thecommon large gel reservoir 1105 through gel conduits 1267 and throughthe common distribution node 1250. Signal lines 1260 may also beprovided for communicating defibrillation and/or pacing pulses, as wellas other electrical signals, between components of the garment 105, forexample, monitor 125 and the receptacles 1145F, 1145R and/or betweenreceptacles 1145F, 1145R and/or common distribution node 1250.

The example shown in FIG. 16 is similar to that shown in FIG. 15 , withthe two separate rear receptacles 1145R combined into a single largerear receptacle 1145R′. The fluid pressure conduit 1165 between the tworear receptacles 1145R of FIG. 15 is eliminated. Signal lines 1260 maybe provided for communicating defibrillation and/or pacing pulses, aswell as other electrical signals between components of the garment 105,for example, monitor 125 and the receptacles 1145F, 1145R and/or betweenreceptacles 1145F, 1145R and/or common distribution node 1250.

Device Features

In one embodiment, at least one of first therapy electrode 135 andsecond therapy electrode 140 includes conductive thread. In oneembodiment, at least one of first therapy electrode 135 and secondtherapy electrode 140 consists only of conductive thread. In oneembodiment, at least one of first therapy electrode 135 and secondtherapy electrode 140 includes conductive thread as well as additionalelectrode components, such as a conductive element that may be stitchedinto garment 105 with the conductive thread. In such embodiments, areceptacle 1145 that does not include a conductive layer may beassociated with each therapy electrode 135, 140 to dispense conductivegel between the electrodes 135, 140 and the body of a subject prior tothe delivery of electrical energy, for example, a defibrillation shockor pacing pulses, to the subject through the therapy electrodes.

In one embodiment, when the subject is defibrillated or paced,conductive gel released from receptacles 1145 reduces impedance betweenfirst therapy electrode 135 and second therapy electrode 140 (orconductive thread, metallic surfaces, or combinations thereof that forma surface of electrodes 135, 140) and the subject's skin. The impedancereduction when conductive gel is released from receptacles 1145 improvesthe efficiency of energy delivery from therapy controller 115 to thesubject and reduces the chance of skin damage in the form of, forexample, burning, reddening, or other types of irritation to the skin.

FIG. 17 depicts an example of conductive gel entering the area between atherapy electrode and the subject's skin. Conductive gel may also besimilarly disposed between sensing electrode 150 and the subject's skin.In one embodiment, conductive gel enters the area between conductivesurface 405 of electrode 135 or 140 and the subject's skin and forms aconduction path 410 from electrode 135 or 140 to the subject's skin. Theconductive gel can cover conductive thread or mesh fabric 415 that ispart of garment 105 and portions of which can be disposed betweensubject's skin and electrode 135 or 140. In the embodiment shown in FIG.17 , the therapy electrode 135, 140 may be formed from a receptacle 1145and the conductive surface 405 may correspond to a conductive surface,for example, conductive surface 1160 disposed on the receptacle 1145.

In one embodiment, after the conductive gel has been deployed tofacilitate treatment, receptacles 1145 can be replaced without replacingadditional garment 105 components, for example, belt 110. For example,belt 110 need not be replaced, and soiled areas of belt 110 can becleaned. As a result the subject need not wait for a replacement belt110, and need not manually add conductive gel to electrodes 135, 140 tomaintain an appropriate electrical connection as a precaution in caseadditional treatment (e.g., shocks) become necessary while waiting for areplacement belt.

In one embodiment, permanently housing or integrating at least one offirst therapy electrode 135 and second therapy electrode 140 in belt 110(or elsewhere in external medical device 100) ensures that they areproperly inserted and configured to deliver a shock to the subjectbecause the subject cannot, in this example, tamper with their locationor configuration, or accidentally improperly insert them into belt 110(e.g., backwards, not properly electrically coupled, or facing the wrongway). In one embodiment, at least one surface or a pad associated withat least one of first therapy electrode 135 and second therapy electrode140 faces the subject's skin to make a sufficient low impedance currentpath between at least one of first therapy electrode 135 and secondtherapy electrode 140 and the subject's skin when the conductive gel isdeployed. For example, first therapy electrode 135 or second therapyelectrode 140 can be housed in a pocket of garment 105, with a surfaceor side wall of garment 105 between the subject's skin and electrode 135or electrode 140 having a metallic mesh pattern. The metallic mesh caninclude silver or other conductive metals to lower impedance between thesubject's skin and the conductive surface of electrode 135 or electrode140.

In one embodiment, at least one of first therapy electrode 135 andsecond therapy electrode 140 are part of or integral to at least one ofexternal medical device 100, garment 105, or belt 110, with conductivegel reservoir 1105 and a deployment mechanism configured in replaceablereceptacle 1145.

FIG. 18 illustrates components of external medical device 100 accordingto one embodiment, with sensing electrodes 150 including at least oneEKG (or ECG) electrocardiogram sensor, conductive thread 505 woven intobelt 110 of garment 105, and receptacle 1145 disposed proximate to firsttherapy electrode 135 in belt 110.

In one embodiment, control unit 1130 instructs receptacle 1145 torelease the conductive gel included in conductive gel reservoir 1105.The released conductive gel reduces impedance between the subject's skinand first therapy electrode 135 and second therapy electrode 140.Therapy controller 115 applies treatment (e.g., a shock) to the subjectvia first therapy electrode 135 and second therapy electrode 140. Duringtreatment, current follows a path between the subject's skin and firsttherapy electrode 135 and second therapy electrode 140 via theconductive gel. In one embodiment, after treatment, the subject removesand discards or recycles the spent receptacles 1145, washes any soiledareas of garment 105, for example, portions of belt 110, and installsreplacement receptacles 1145. The subject or external medical device 100may carry spare receptacles 1145. In one embodiment, the subject maywear a backup external medical device 100 during this changeover period.

In one embodiment external medical device 100 indicates to the subjectwhether or not receptacles 1145 have been properly inserted. Forexample, audio, visual, or haptic signals, or combinations thereof, canbe provided by alarm module 120 or monitor 125. By incorporating atleast one of first therapy electrode 135 and second therapy electrode140 and associated wiring into external medical device 100, garment 105is more comfortable for the subject wearing it. There are fewercomponents to assemble and maintain, and to cause subject discomfortduring use.

Receptacle 1145 may also include a control unit 1130 to controlconductive fluid delivery and to communicate with therapy controller115, and a connection port 1210, for example, a winding of an inductioncoil (or other interface such as a connector) to interface with one ormore components of the garment 105, for example, alarm module 120 and/ormonitor 125.

In one embodiment, the conductive gel includes a gel, liquid, or othermaterial that lowers impedance for energy transfer between electrodes135, 140, and the subject. The conductive gel can remain on thesubject's skin for a period of time, for example, several hours beforeit is removed, and the conductive gel remains functional as an impedancereducing material during this time period. The conductive gel in oneembodiment also has sufficient shelf life to remain dormant for a periodof time prior to use. In one embodiment, receptacle 1145 indicates anexpiration date of the conductive gel. Control unit 1130 can determinethe expiration date and, upon or prior to expiration, indicate via alarmmodule 120 or monitor 125 that receptacle 1145 should be replaced.

In one embodiment, receptacle 1145 can include control unit 1130 tocommunicate with therapy controller 115 to release the conductive gel atthe appropriate time. Information communicated between the receptacle1145 and therapy controller (via at least one control unit 1130 locatedon receptacle 1145, therapy controller 115, garment 105, or combinationsthereof) includes: the presence or absence of receptacle 1145; whetheror not the conductive gel has been released from receptacle 1145; afault condition that can occur if receptacle 1145 has been commanded torelease the conductive gel but the conductive gel has failed to release;the integrity of gas and/or fluid chambers associated with pressuresensor 1220 that are configured to deliver pressure to conductive gelreservoir 1105 to release the conductive gel; and the age of theconductive gel based, for example, on the date of manufacture of theconductive gel or of receptacle 1145.

In one embodiment, receptacles 1145 are replaceable subunits of garment105. The subject can be supplied with spare receptacles 1145 so thatspent or consumed receptacles 1145 can be quickly replaced in the eventof their use during treatment, providing continuous or essentiallycontinuous protection without having to replace belt 110, electrodes 135or 140, or other wearable therapeutic device components. Receptacle 1145may also include control unit 1130 to control conductive fluid deliveryand to communicate with therapy controller 115, and connection port 1210(for example, a winding of an induction coil or another form ofconnector as discussed above) to interface with garment 105.

FIG. 19 illustrates an example of the connection between receptacle 1145and therapy controller 115 via interface 805. FIG. 19 , as well as FIGS.20 and 21 described below, illustrate positioning sensing circuits 1225located external to receptacle 1145, for example, in a control unit 1130separate from the receptacle 1145, and on receptacle 1145. Someembodiments may have redundant sensing circuits 1225 as illustrated orsensing circuits 1225 configured to sense different parameters, while inother embodiments, only a single sensing circuit 1225 is provided, forexample, within the control unit 1130, if separate from the receptacle1145, or in the receptacle 1145 itself.

In one embodiment, pressure sensor 1220 detects if gel conduit 1165 beencompromised. The gel conduit 1165 may be purged such that its contentschange color when exposed to air. In one embodiment, there can be avacuum on the gel conduit 1165, and pressure sensor 1220 detects whenthe gel conduit 1165 has been compromised based on changes in itspressure. In one embodiment, therapy controller 115 detects when, or isinformed by sensing circuit 1225 that the conductive fluid has beenreleased, when receptacle 1145 has a fault condition, is missing, orimproperly inserted, and when the conductive fluid is expired orapproaching expiration. Therapy controller 115 may then indicate thisstatus condition to the subject via its own monitor or interface, or viaalarm module 120 or monitor 125, so that the subject can take theappropriate action.

With reference to FIGS. 4 and 20 , among others, a connection port 1210forming a connection between receptacle 1145 and therapy controller 115via garment 105 can incorporate an induction coil, a capacitivecoupling, RF and/or IR link, other wireless connections, magnets, or canbe a hardwire connection using a connector. The connection allowsreceptacle 1145 to be removed and replaced, for example, after theconductive fluid has been released at the appropriate time duringtreatment.

Portions of gel deployment control unit 1130 can be located entirely onreceptacle 1145, entirely external to receptacle 1145, or both onreceptacle 1145 and external to receptacle 1145 at other locations ofexternal medical device 100. For example, components of any of sensingcircuit 1225, pressure sensor 1220, positioning sensor 810, andactivator circuit 1230 can be part of receptacle 1145, external toreceptacle 1145, or connected to receptacle 1145 via a connection port120, for example, an induction coil.

FIG. 20 and FIG. 21 depict examples where a connection port 1210including an induction coil connects receptacle 1145 with garment 105and therapy controller 115. In one embodiment, receptacle 1145electromagnetically couples with garment 105 via at least one inductioncoil. In one embodiment, a first winding of the induction coil isdisposed on receptacle 1145 and a second winding is disposed in garment105. When receptacle 1145 is inserted into place in garment 105, thefirst and second windings are brought into position to form anelectromagnetic coupling between receptacle 1145 and therapy controller115 via garment 105 and its wiring. In one embodiment, the inductioncoil permits close proximity communication and power transfer betweenreceptacle 1145 and garment 105 (and garment 105's components) without ahardwired connection via a connector. The induction coil may be at leastpartially woven, sewn, or embroidered with conductive elements intogarment 105 or components thereof such as therapy pads of electrodes135, 140. In one embodiment, as illustrated in FIG. 20 , power forreceptacle 1145 is provided by capacitor 905, with the induction coiltransferring power to receptacle 1145 from power supply 1905 to chargecapacitor 905. In one embodiment, converter 910 converts AC power frompower supply 1905 to DC power that can be provided to any of sensingcircuit 1225, pressure sensor 1220, activator circuit 1230, orpositioning sensor 810. Power for receptacle 1145 can also be providedby battery 1215 as illustrated in FIG. 21 .

In one embodiment, receptacles 1145 are packaged as individual selfcontained units. For example, in a wearable therapeutic device includingone first therapy electrode 135 and two second therapy electrodes 140,three receptacles 1145 (one for each of the three therapy electrodes)can be identical.

In one embodiment, receptacles 1145 are packaged as individual selfcontained units. For example, with one first therapy electrode 135 andtwo second therapy electrodes 140, three receptacles 1145 (one for eachof the three therapy electrodes) can be identical, as illustrated inFIG. 22 .

In one embodiment, garment 105 includes conductive thread 505 to formelectrical connections between areas of garment 105 and between externalmedical device 100 components. First therapy electrode 135, secondtherapy electrode 140, and sensing electrode 150 can include conductivethread 505 or metallic surfaces sewn into garment 105. Conductive thread505 can also provide connections between any of electrodes 135, 140, and150 and battery powered wearable therapy controller 115. In oneembodiment, sensing electrodes 150 pick up the subject's ECG (EKG)signals and provide those signals to therapy controller 115 and/ormonitor 125. Therapy electrodes 135, 140 and the conductive fluid formpart of a current path to transfer energy from therapy controller 115 tothe subject.

In one embodiment, electrodes 135, 140, and/or 150 include conductivestitching 505 in various patterns to achieve proper EKG sensing and toadminister therapy. In one embodiment, at least one of electrodes 135,140, and 150 include only conductive stitching 505. Garment 105 mayinclude an elastic material. An example of this is illustrated in FIG.23 , where connection snap 1505 can electrically couple at least one ofelectrodes 135, 140, and 150 with other components of external medicaldevice 100 such as garment 105, receptacles 1145 or therapy controller115. In one embodiment, at least one of electrodes 135, 140, and 150includes conductive stitching 505 that holds a metal foil 1605 or otherconductive component in place in garment 105. In this example, at leasta portion of at least one of electrodes 135, 140, and 150 includesconductive thread 505 and metal foil 1605. An example of this isillustrated in FIG. 24 .

In one embodiment, conductive thread 505 is sewn into garment 105 (e.g.,belt 110) in a zigzag pattern that can stretch as part of garment 105.This stretchable conductive thread stitching 505 connects therapyelectrodes 135 and 140 with control unit 130 or other garment 105components (e.g., therapy controller 115, receptacle 1145, and sensingelectrode 150) in the absence of additional wires. Conductive thread(e.g., conductive wiring) 505 can face toward or away from the subject'sskin. In one embodiment, conductive stitching 505 faces towardreceptacle 1145 and away from the subject's skin so as to not irritatethe subject. When the conductive fluid releases, it contacts theconductive thread 505 and spreads through at least a portion of garment105 and contacts the subject's skin. In one embodiment, an elastictension member of garment 105 is positioned proximate to receptacle 1145to hold receptacle 1145 in position proximate to one of electrodes 135and 140. When conductive stitching 505 faces toward the subject's skin,electrical contact between the electrodes 135 and/or 140 and thesubject's skin can occur in the absence of conductive fluid.

FIG. 25 and FIG. 26 are schematic diagrams depicting an embodiment wheregarment 105 includes conductive pads 1805 and magnets 1810 to aligngarment 105 with receptacle 1145 to facilitate electrical couplingbetween garment 105 and receptacle 1145. Conductive pads 1805 mayinclude conductive thread 505 or other textile materials woven intogarment 105 to provide current from a current source to receptacles1145. The current source can be housed within or remote from externalmedical device 100. In one example, magnets 1810 are disposed proximateto conductive pads 1805. Receptacle 1145 can also include magnets 1810.Magnets 1810 provide magnetic force (attractive or repulsive) betweengarment 105 and receptacle 1145 to align conductive pads 1805 withcontact elements 1815 of receptacle 1145. For example, attractivemagnetic forces between magnets 1810 on garment 105 and receptacle 1145can indicate alignment between conductive pads 1805 and contact elements1815 of receptacle 1145, or repulsive magnetic forces can indicateimproper alignment, facilitating the insertion of receptacle 1145 intogarment 105. Receptacle 1145 can include conductive contact elements1815 that align with conductive pads 1805 when receptacle is properlypositioned in garment 105. Forces from magnets 1810 align conductivecontact elements 1815 with conductive pads 1805 to provide an electricalconnection between components of garment 105 and receptacle 1145.Current may pass via this electrical connection, under control ofcontrol unit 130, to release conductive fluid from receptacles 1145. Inone embodiment, receptacle 1145 is disposed in a pocket of garment 105,and magnets 1810 are disposed in garment 105 on opposite sides ofreceptacle 1145 when disposed in the pocket. In one embodiment, magnets1810 are coated, for example in plastic, to protect from wear, damage(e.g., during washing), or high moisture conditions. In one embodiment,conductive pad 1805 is at least part of electrode 135, 140, or 150. Insome embodiments, the magnets 1810 and the conductive pads 1805 on thegarment may be combined into conductive magnetic elements. In someembodiments, the magnets 1810 and conductive contact elements 1815 onthe receptacle 1145 may be combined into conductive magnetic contactelements.

In one embodiment, garment 105 includes snaps to align garment 105 withreceptacle 1145 to facilitate electrical coupling between garment 105and receptacle 1145. For example, snaps can fix garment 105 in positionwith contact elements 1815 aligned with conductive pads 1805.

The foregoing is illustrative and not limiting, having been presented byway of example. In particular, although many of the examples presentedherein involve specific combinations of or system elements, it isunderstood that those acts and those elements may be combined in otherways. Acts, elements and features discussed only in connection with oneembodiment are not excluded from a similar role in other embodiments.

Note that in FIGS. 1 through 26 , the enumerated items are shown asindividual elements. In actual implementations of the systems andmethods described herein, however, they may be inseparable components ofother electronic devices such as a digital computer. Thus, actionsdescribed above may be implemented at least in part in software that maybe embodied in an article of manufacture that includes a program storagemedium. The program storage medium includes data signals embodied in oneor more of a carrier wave, a computer disk (magnetic, or optical (e.g.,CD or DVD, or both)), non-volatile memory, tape, a system memory, and acomputer hard drive. The program storage medium can include at leastnon-transient mediums, and the signals can include at leastnon-transient signals.

From the foregoing, it is appreciated that the wearable therapeuticdevice provided herein affords a simple and effective way toautomatically apply and immediately provide lifesaving care to a subjectduring a cardiac event without any human intervention.

Any references to embodiments or elements or acts of the systems andmethods herein referred to in the singular may also embrace embodimentsincluding a plurality of these elements, and any references in plural toany embodiment or element or act herein may also embrace embodimentsincluding only a single element. References in the singular or pluralform are not intended to limit the presently disclosed systems ormethods, their components, acts, or elements to single or pluralconfigurations.

Any embodiment disclosed herein may be combined with any otherembodiment, and references to “an embodiment,” “some embodiments,” “analternate embodiment,” “various embodiments,” “one embodiment” or thelike are not necessarily mutually exclusive and are intended to indicatethat a particular feature, structure, or characteristic described inconnection with the embodiment may be included in at least oneembodiment. Such terms as used herein are not necessarily all referringto the same embodiment. Any embodiment may be combined with any otherembodiment in any manner consistent with the aspects and embodimentsdisclosed herein.

References to “or” should be construed as inclusive so that any termsdescribed using “or” may indicate any of a single, more than one, andall of the described terms. Intervening embodiments, acts, or elementsare not essential unless recited as such.

Where technical features in the drawings, detailed description or anyclaim are followed by references signs, the reference signs have beenincluded for the sole purpose of increasing the intelligibility of thedrawings, detailed description, and claims. Accordingly, neither thereference signs nor their absence have any limiting effect on the scopeof any claim elements.

One skilled in the art will realize the systems and methods describedherein may be embodied in various forms. The foregoing embodiments areillustrative rather than limiting of the described systems and methods.Scope of the systems and methods described herein is thus indicated bythe appended claims, rather than the foregoing description, and changesthat come within the meaning and range of equivalency of the claims areembraced therein.

What is claimed is:
 1. A therapy electrode system for deployingconductive gel prior to delivering electrical therapy to a patient,comprising: a plurality of therapy electrodes disposed in a garment andconfigured to deliver one or more electrical shocks to a body of thepatient, each of the plurality of therapy electrodes including a gelchamber configured to store conductive gel; a plurality of aperturesdefined in lower surfaces of each of the plurality of therapyelectrodes, the plurality of apertures of each respective therapyelectrode in fluid communication with the gel chamber of each respectivetherapy electrode; a distribution node in electrical communication witheach of the plurality of therapy electrodes through signal lines and influid communication with each of the plurality of therapy electrodesthrough fluid pressure conduits; an air pump disposed on thedistribution node and in fluid communication with the gel chambers ofeach of the plurality of therapy electrodes through the fluid pressureconduits; and a controller configured to: detect a life-threateningarrhythmia event occurring in a patient; cause the air pump to applypressurized air directly or indirectly to the gel chambers of each ofthe plurality of therapy electrodes to release the conductive gel viathe plurality of apertures on to the body of the patient; and afterrelease of the conductive gel, cause the plurality of therapy electrodesto deliver the one or more electrical shocks to the body of the patient.2. A therapy electrode system for deploying conductive gel prior todelivering electrical therapy, comprising: a plurality of therapyelectrodes disposed in a garment and configured to deliver one or moreelectrical shocks to a body of the patient; a gel chamber associatedwith at least one of the plurality of therapy electrodes, the gelchamber configured to store conductive gel; a pressure sensor configuredto provide an indication of whether the gel chamber is intact; aplurality of apertures defined in a lower surface of the at least one ofthe plurality of therapy electrodes, the plurality of apertures in fluidcommunication with the gel chamber; a fluid pump in fluid communicationwith the gel chamber, the fluid pump configured to be removable from thetherapy electrode system after use such that the fluid pump is reusablewith a different therapy electrode system; and a controller configuredto: detect a life-threatening arrhythmia event occurring in a patient;cause the fluid pump to apply working fluid directly or indirectly tothe gel chamber to release the conductive gel via the plurality ofapertures on to the body of the patient; and after release of theconductive gel, cause the plurality of therapy electrodes to deliver theone or more electrical shocks to the body of the patient.
 3. The systemof claim 2, wherein the conductive gel is contained within a bladderdisposed within the gel chamber.
 4. The system of claim 2, wherein theworking fluid comprises air.
 5. The system of claim 2, wherein theworking fluid is physically separated from the conductive gel by amembrane such that pressure applied by the fluid on one side of themembrane can cause the conductive gel that is disposed on the other sideof the membrane to be deployed.
 6. The system of claim 2, wherein thefluid pump is disposed in a cartridge removably attached to the at leastone of the plurality of therapy electrodes.
 7. The system of claim 2,configured to cause the working fluid to indirectly apply pressure tothe conductive gel.
 8. The system of claim 2, configured to cause theworking fluid to directly apply pressure to the conductive gel.
 9. Thesystem of claim 2, wherein each of the plurality of therapy electrodesis electrically connected to a common distribution node.
 10. The systemof claim 2, wherein the gel chamber is defined in a shell of the atleast one of the plurality of therapy electrodes.
 11. The system ofclaim 2, further comprising a sensing circuit configured to detect if adesired impedance value is reached and cause the fluid pump to be turnedoff responsive to the desired impedance value having been reached.
 12. Awearable device for deploying conductive gel prior to deliveringelectrical therapy, comprising: a garment configured to be worn about atorso of a patient; a plurality of therapy electrodes disposed in thegarment and configured to deliver one or more electrical shocks to abody of the patient; a gel chamber associated with at least one of theplurality of therapy electrodes, the gel chamber configured to storeconductive gel; a plurality of apertures defined adjacent one or more ofthe plurality of therapy electrodes, the plurality of apertures in fluidcommunication with the gel chamber; a fluid pump in fluid communicationwith the gel chamber, the fluid pump configured to be removable from thetherapy electrode system after use such that the fluid pump is reusablewith a different therapy electrode system; a sensing circuit configuredto detect if a desired impedance value is reached and cause the fluidpump to be turned off responsive to the desired impedance value havingbeen reached; and a controller configured to: detect a life-threateningarrhythmia event occurring in the patient; cause the fluid pump to applyworking fluid directly or indirectly to the gel chamber to release theconductive gel via the plurality of apertures on to the body of thepatient; and after release of the conductive gel, cause the plurality oftherapy electrodes to deliver the one or more electrical shocks to thebody of the patient.
 13. The device of claim 12, further comprising apressure sensor configured to provide an indication of whether the gelchamber is intact.
 14. The device of claim 12, wherein the conductivegel is contained within a bladder disposed within the gel chamber. 15.The device of claim 12, wherein the conductive gel is disposed in directcontact with internal surfaces of the gel chamber.
 16. The device ofclaim 12, wherein at least one of the plurality of therapy electrodes isintegral to the garment.
 17. The device of claim 12, wherein the workingfluid comprises air.
 18. The device of claim 12, wherein the pluralityof apertures are arranged in pairs, each pair of apertures being asubstantially same distance from an end of the therapy electrode. 19.The device of claim 18, wherein the plurality of apertures are sizedsuch that upon dispensing of the conductive gel, a substantially sameamount of conductive gel flows through each of the apertures.
 20. Thedevice of claim 12, wherein the fluid pump is disposed in a cartridgeremovably attached to the at least one of the plurality of therapyelectrodes.
 21. The device of claim 12, wherein the working fluid isphysically separated from the conductive gel by a membrane such thatpressure applied by the fluid on one side of the membrane can cause theconductive gel that is disposed on the other side of the membrane to bedeployed.